Study Evaluating the Efficacy of DVS-233 in Fibromyalgia

This study has been terminated.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00301431
First received: March 8, 2006
Last updated: December 3, 2007
Last verified: December 2007
  Purpose

The purpose of this study is to determine if DVS-233 is safe and effective in the treatment of pain and other symptoms of fibromyalgia syndrome.


Condition Intervention Phase
Fibromyalgia
Drug: DVS-233
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Adaptive Design, Efficacy and Tolerability Study of 4 Fixed Doses of DVS-233 in Adult Outpatients With Fibromyalgia Syndrome

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • The primary outcome will be the change in the daily pain score from baseline to study day 105 of therapy.

Secondary Outcome Measures:
  • Fibromyalgia Impact Questionnaire and the Patient Global Impression of Change

Estimated Enrollment: 1050
Study Start Date: August 2006
Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fibromyalgia according to 1990 American College of Rheumatology (ACR) criteria

Exclusion Criteria:

  • Other painful conditions that may make results difficult to interpret.
  • Treatment with other drugs for fibromyalgia with 14 days of study start or during the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301431

  Hide Study Locations
Locations
United States, Alabama
Huntsville, Alabama, United States, 35801
Mobile, Alabama, United States, 36608
United States, Arizona
Phoenix, Arizona, United States, 85016
United States, California
Anaheim, California, United States, 92801
Sacramento, California, United States, 95825
San Diego, California, United States, 92108
Santa Ana, California, United States, 92705
Walnut Creek, California, United States, 94598
United States, Colorado
Denver, Colorado, United States, 80218
United States, Connecticut
Cromwell, Connecticut, United States, 06416
United States, Florida
Brooksville, Florida, United States, 33613
Deland, Florida, United States, 32720
Delray Beach, Florida, United States, 33484
Jacksonville, Florida, United States, 32216
Miami, Florida, United States, 33173
Palm Beach Gardens, Florida, United States, 33418
Pembroke Pines, Florida, United States, 33026
St. Petersburg, Florida, United States, 33709
Sunrise, Florida, United States, 33351-6637
Tamarac, Florida, United States, 33321
Tampa, Florida, United States, 33606
United States, Georgia
Atlanta, Georgia, United States, 30342
Decatur, Georgia, United States, 30033
Smyrna, Georgia, United States, 30080
United States, Illinois
Chicago, Illinois, United States, 60612
Chicago, Illinois, United States, 60611
United States, Indiana
Indianapolis, Indiana, United States, 46202
United States, Kentucky
Lexington, Kentucky, United States, 40509
Lexington, Kentucky, United States, 40536-0284
United States, Maryland
Rockville, Maryland, United States, 20852
United States, Massachusetts
Boston, Massachusetts, United States, 02115
Newton, Massachusetts, United States, 02462
United States, Michigan
Lansing, Michigan, United States, 48910
United States, Missouri
Kansas City, Missouri, United States, 64114
St. Louis, Missouri, United States, 63117
United States, Nevada
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Clementon, New Jersey, United States, 08021
United States, North Carolina
Raleigh, North Carolina, United States, 27612
United States, Ohio
Cincinnati, Ohio, United States, 45219
Dayton, Ohio, United States, 45408
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73103
Oklahoma City, Oklahoma, United States, 73112
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Duncansville, Pennsylvania, United States, 16635
Harleysville, Pennsylvania, United States, 19438
Philadelphia, Pennsylvania, United States, 19149
Philadelphia, Pennsylvania, United States, 19152
Sellersville, Pennsylvania, United States, 18960
West Reading, Pennsylvania, United States, 19611
United States, Rhode Island
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Charleston, South Carolina, United States, 29407
Summerville, South Carolina, United States, 29485
United States, Tennessee
Bristol, Tennessee, United States, 37620
Chattanooga, Tennessee, United States, 37404
Memphis, Tennessee, United States, 38119
United States, Texas
Austin, Texas, United States, 78756
Dallas, Texas, United States, 75231
San Antonio, Texas, United States, 78205
United States, Wisconsin
Middleton, Wisconsin, United States, 53562
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00301431     History of Changes
Other Study ID Numbers: 3151A4-327
Study First Received: March 8, 2006
Last Updated: December 3, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Fibromyalgia
Adults
Outpatients
Adult
Double-Blind Method

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 30, 2014